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The aims of this study are to compare the effectiveness of antifungal foam versus antifungal shampoo and determine patient compliance and satisfaction with both vehicles among African American females with dandruff practicing less than once weekly hair washing.
A wide variety of topical vehicles are available for medications that treat scalp disorders. Proper vehicle selection is important when managing scalp conditions, such as seborrheic dermatitis, because the efficacy of these treatments depends largely on compliance and the amount of active ingredient delivered to the scalp. It is therefore important to prescribe vehicles that are easy to apply and cause the least amount of disruption to the patients' pre-existing hair care practices. One of the most common rate limiting hair care practices among different cultures is wash frequency. Literature shows African American women are more likely to wash their hair less than once weekly versus Caucasian women. We hypothesize certain vehicles, such as foam preparations which do not require hair washing, will be more efficacious in African American women with seborrheic dermatitis than shampoo preparations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shampoo Group | Active Comparator | Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. |
|
| Foam group | Active Comparator | Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. |
|
| Cross Over Group | Active Comparator | apply ketoconazole 2% foam to scalp twice daily for four weeks. Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period using shampoo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketoconazole 2% foam | Drug | Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Dandruff Severity Score (TDSS) | The scalp will be divided into quadrants and for each quadrant the percent of involvement and degree of severity will be assessed. The percent of involvement will be measured on a scale of 0 to 4 in which a score of 0 means less than 10% involvement, and a score of 4, more than 76% involvement. Severity will be measured on a scale of 0 to 3 in which a score of 0 indicates normal skin, and a score of 3, marked erythema with thick confluent plates of yellowish white scales. The whole scalp score will then calculated by multiplying the total percent involvement score by the total severity score. Quadrant scalp score = percent involvement score x severity score Total scalp score = summation of all the quadrant scores TDSS value ranges from 0-48, with 0 equal to no scale, which is the best outcome, compared to 48, which is the most severe and worse outcome | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Are Always Compliant. | Patient compliance will be evaluated by having patients keep a diary documenting the use of study drug. They will also be questioned about their medication usage at every visit. In addition, we will weigh the study drug at every visit. a patient is classified as always indicates that they use their medicine as directed on their diary on every visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aibing M Guo, M.D. | St. Louis University Dermatology | Principal Investigator |
| Scott W Fosko, M.D. | St. Louis University Dermatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis University Department of Dermatology | St Louis | Missouri | 63104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Shampoo Only Group | Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. |
| FG001 | Foam Only Group | Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. |
| FG002 | Shampoo First and Then Foam | subjects used shampoo for 4 weeks, but did not reach 60% improvement on TDSS score were given foam treatment for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 4 Weeks Treatment |
| |||||||||||||
| Cross Over Period 4 Weeks Treatment |
|
Subjects in the S group were able to cross over into the F group if the TDSS score does not improve by 60% at the end of the 4 week treatment period. These cross over subjects remained in the study for an additional 4 weeks to apply ketoconazole foam 2%. The 4 subject in the cross over group were originally in the shampoo group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Shampoo Group | Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. |
| BG001 | Foam Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Dandruff Severity Score (TDSS) | The scalp will be divided into quadrants and for each quadrant the percent of involvement and degree of severity will be assessed. The percent of involvement will be measured on a scale of 0 to 4 in which a score of 0 means less than 10% involvement, and a score of 4, more than 76% involvement. Severity will be measured on a scale of 0 to 3 in which a score of 0 indicates normal skin, and a score of 3, marked erythema with thick confluent plates of yellowish white scales. The whole scalp score will then calculated by multiplying the total percent involvement score by the total severity score. Quadrant scalp score = percent involvement score x severity score Total scalp score = summation of all the quadrant scores TDSS value ranges from 0-48, with 0 equal to no scale, which is the best outcome, compared to 48, which is the most severe and worse outcome | Data were not collected for the Shampoo only group and Foam Only group at 8 weeks. Only 3 participants completed the 8 weeks of cross over treatment. | Posted | Mean | Standard Deviation | units on a scale | up to 8 weeks |
|
36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shampoo Only Group | Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aibing Mary Guo, M.D., Assistant Professor | Saint Louis Univ Hospital | 3142563430 | aguo@slu.edu |
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| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| D063807 | Dandruff |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| ketoconazole 2% shampoo | Drug | Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. |
|
|
| at end of each treatment period (4 weeks and 8 weeks) |
| Number of Participants Who Are Very Satisfied | Patient satisfaction will be measured using a five point satisfaction scale.
| data were collected at end of each treatment period (4 weeks and 8 weeks) |
| NOT COMPLETED |
|
Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. |
| BG002 | Cross Over Group | Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group. ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Shampoo Only Group | Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. |
| OG001 | Foam Only Group | Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. |
| OG002 | Cross Over Group | Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group. ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. |
|
|
| Secondary | Number of Participants Who Are Always Compliant. | Patient compliance will be evaluated by having patients keep a diary documenting the use of study drug. They will also be questioned about their medication usage at every visit. In addition, we will weigh the study drug at every visit. a patient is classified as always indicates that they use their medicine as directed on their diary on every visit. | Data were not collected for the Shampoo Only Group and Foam Only Group at end of 8 weeks. Only 3 participants finished the study in the Cross Over Group. | Posted | Count of Participants | Participants | at end of each treatment period (4 weeks and 8 weeks) |
|
|
|
| Secondary | Number of Participants Who Are Very Satisfied | Patient satisfaction will be measured using a five point satisfaction scale.
| Data were not collected for the Shampoo Only Group and Foam Only Group at end of 8 weeks. Only 3 participants finished the study in the Cross Over Group. | Posted | Count of Participants | Participants | data were collected at end of each treatment period (4 weeks and 8 weeks) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Foam Only Group | Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Cross Over Group | Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group. ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |
| D012536 | Scalp Dermatoses |
| compliance at week 8 |
|
|
| Very Satisfied at 8 weeks |
|
|